BAN
HARVEST® - 51448
Device Description
A collection of sterile devices intended to be used to prepare and/or deliver bone graft material during an orthopaedic surgical procedure. It typically includes aspirating/delivery/mixing syringe(s), an adaptor, and a needle/cannula. It allows for the aspiration and/or premixing of bone marrow, autologous blood, plasma, intravenous fluids (IVF), and bone void filler (e.g., allograft, autograft, synthetic bone graft material), and their delivery to the surgical site. This is a single-use device.
Environmental Conditions
- 25.00
- 0.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: FMF
Device Name: Syringe, Piston
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: HO
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 880.5860
Third Party Flag: Y
Medical Specialty: HO
Device IdentifiersDevice Id: 05020583514485
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
Device Id: 35020583514486
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 05020583514485
Package Quantity: 3
Package Discontinue Date: 2/14/2023 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: N/A